The following data is part of a premarket notification filed by Envision, Inc. with the FDA for Envision G21 I/a Enpak.
| Device ID | K832423 |
| 510k Number | K832423 |
| Device Name: | ENVISION G21 I/A ENPAK |
| Classification | Unit, Phacofragmentation |
| Applicant | ENVISION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-22 |
| Decision Date | 1983-09-12 |